Prospect: information for the patient

Zilbrysq 16.6 mg, injectable solution in preloaded syringe

Zilbrysq 23 mg, injectable solution in preloaded syringe

Zilbrysq 32.4 mg, injectable solution in preloaded syringe

zilucoplan

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this prospect. See section 4.

Zilbrysq contains the active ingredient zilucoplan. Zilucoplan binds to a protein in the body that produces inflammation, blocking it, known as the complement C5 protein, which is part of the immune system (the body's natural defenses). By blocking this protein, zilucoplan prevents the body's immune system from attacking and destroying the connections between nerves and muscles, thus improving the symptoms of the disease.

Zilbrysq is used in conjunction with standard treatment to treat adult patients with generalized myasthenia gravis (MGg), an autoimmune disease that produces muscle weakness. It is used in adults whose immune system produces antibodies against a protein called the acetylcholine receptor, located in muscle cells. In patients with MGg, the immune system can attack and damage muscles, which can cause intense muscle weakness, mobility deterioration, shortness of breath, extreme fatigue, difficulty swallowing, and functional deterioration in performing daily activities.

Zilbrysq may reduce disease symptoms and improve quality of life.

Do not use Zilbrysq

• if you are allergic to zilucoplan or any of the other components of this medication (listed in section 6).
• if you have not been vaccinated against meningococcal infection. See Advertencias y precauciones section.
• if you have any meningococcal infection

Advertencias y precauciones

Warning about meningococcal infections and other infections byNeisseria

Because Zilbrysq inhibits the body's natural defenses against infections, its use may increase the risk of infections caused byNeisseria meningitidis,such as meningococcal infection (serious infection of the membranes covering the brain and spinal cord and/or infection in the blood) and also of other infections caused by the bacteriumNeisseria, such as gonorrhea.

Consult your doctor before using Zilbrysq to ensure that you are vaccinated againstNeisseria meningitidis, a microorganism that produces meningococcal infections, at least 2 weeks before starting treatment. If you cannot be vaccinated 2 weeks in advance, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after receiving your first dose of the vaccine. Make sure your meningococcal vaccinations are up to date.

You should know that vaccination does not always prevent this type of infection.

If you are at risk of developing gonorrhea (bacterial sexually transmitted infection), ask your doctor before starting to use this medication.

Meningococcal infection symptoms

Due to the importance of identifying and quickly treating meningococcal infections in patients receiving Zilbrysq, you will be given a card to carry with you at all times, which lists specific signs and symptoms of possible meningococcal infection. It also contains information for healthcare professionals who may not be familiar with Zilbrysq. This card is called: “Patient Alert Card”. You will also be given a patient/caregiver guide that contains additional information about Zilbrysq.

Inform your doctor immediately if you have any of these symptoms:

• Headache with additional symptoms, such as nausea (sensation of dizziness), vomiting, fever, and neck or back stiffness
• Fever with or without skin rash
• Sensitivity to light
• Confusion/drowsiness
• Muscle pain with flu-like symptoms

Treatment of meningococcal infections during travel

If you travel to a region where you cannot contact your doctor or receive temporary medical treatment, your doctor may prescribe an antibiotic againstNeisseria meningitidisfor you to carry with you. If you have any of the described symptoms, take the antibiotic treatment as prescribed. Note that you should see a doctor as soon as possible, even if you feel better after taking the antibiotic treatment.

Children and adolescents

Do not administer this medication to children under 18 years of age. Zilbrysq has not been studied in this age group.

Other medications and Zilbrysq

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is uncertainty about the effects Zilbrysq may have on the fetus, so do not use this medication if you are pregnant or think you may be, unless your doctor recommends it specifically.

Zilbrysq is not known to pass into breast milk. There may be a risk in newborns/babies.

Make the decision to stop breastfeeding or Zilbrysq treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman.

Driving and operating machines

It is unlikely that Zilbrysq will affect your ability to drive or operate machines.

Zilbrysq contains sodium

This medication contains less than 1 mmol (23mg) of sodium per pre-filled syringe; it is essentially “sodium-free”.

At least 2 weeks before starting treatment with Zilbrysq, your doctor will administer a vaccine against meningococcal infection if you have not received it before or if you need to renew your vaccination. If you cannot be vaccinated at least 2 weeks before starting treatment with Zilbrysq, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after receiving your first dose of the vaccine.

Before starting treatment, you must also consult your doctor if you need any other vaccine.

After proper training, your doctor will allow you to administer Zilbrysq yourself. Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor again.

The dose you receive will depend on your body weight. Administer your daily dose at the same time of day, more or less.

The following table indicates the total daily dose of Zilbrysq according to your body weight:

How to administer Zilbrysq

You and your doctor or nurse will decide if you can administer this medication yourself. Do not administer this medication yourself unless a healthcare professional has taught you how to do it. Another person can also give you the injections after receiving training.

Zilbrysq will be administered as a subcutaneous injection (a shot under the skin) once a day. It can be injected in the abdominal area, the front of the thighs, or the outer surface of the upper arm. The injections in the outer surface of the upper arms should only be given by another person. The injection site should be changed each time, avoiding areas where the skin is sensitive, bruised, red, or hardened, or where there are scars or stretch marks.

It is essential to read the usage instructions found at the end of the leaflet to obtain detailed information on how to use Zilbrysq.

If you use more Zilbrysq than you should

If you suspect you have received an accidental higher dose of Zilbrysq than prescribed, ask your doctor for advice.

If you forget to use Zilbrysq

If you have not injected the dose at the usual time or forgot a dose, administer it as soon as you remember and then continue with the administration at the usual time the next day. Do not administer more than one dose per day.

If you interrupt the treatment with Zilbrysq

Stopping or suspending treatment with Zilbrysq may cause your symptoms to reappear. Talk to your doctor before stopping Zilbrysq. Your doctor will explain the possible side effects and risks. It may be necessary for your doctor to monitor you closely.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very Frequent(may affect more than 1 person in every 10)

• Reactions at the injection site, such as bruising, pain, itching, and the formation of lumps.
• Nasal and throat infections.

Frequent(may affect up to 1 person in every 10)

• Diarrhea
• Elevation of pancreatic enzymes (amylase, lipase) in blood tests.
• Morpha (a condition that causes localized discoloration and hardening of the skin)

Rare(may affect up to 1 person in every 100)

• Elevation of eosinophils (a type of white blood cell) in blood tests.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the syringe label and on the box after EXP/CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C).

Do not freeze.

Keep the preloaded syringe in the outer packaging to protect it from light.

You can store the preloaded Zilbrysq syringe at room temperature in its original box at a maximum temperature of 30 °C for a single period of up to 3 months. Once Zilbrysq has been removed from the refrigerator, it should not be returned to it. The product should be discarded if it is not used within 3 months, or if the expiration date is reached (whichever occurs first).

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Zilbrysq

• The active principle is: zilucoplan.
• The other components are: sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, sodium chloride, water for injection. (see section 2, “Zilbrysq contains sodium”).

Appearance of Zilbrysq and contents of the pack

Zilbrysq is a pre-filled syringe (injectable) and is between transparent and slightly opalescent and colourless, without visible particles.

Zilbrysq 16.6 mg, pre-filled syringe

Each pre-filled syringe with a purple plunger contains zilucoplan sodium equivalent to 16.6 mg of zilucoplan in 0.416 ml.

Zilbrysq 23 mg, pre-filled syringe

Each pre-filled syringe with an orange plunger contains zilucoplan sodium equivalent to 23 mg of zilucoplan in 0.574 ml.

Zilbrysq 32.4 mg, pre-filled syringe

Each pre-filled syringe with a dark blue plunger contains zilucoplan sodium equivalent to 32.4 mg of zilucoplan in 0.810 ml.

Size of the pack: 7 pre-filled syringes for 16.6 mg, 23 mg and 32.4 mg of injectable solution.

Multiple pack of 28 (4 packs of 7) pre-filled syringes.

Only some pack sizes may be marketed.

Marketing authorisation holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium

Manufacturer

UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium.

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicinal products.

Instructions for use of Zilbrysq, pre-filled syringe

Read ALL the following instructions before using Zilbrysq

Before use

After use

Important information:

• Your healthcare professional must teach you how to prepare and inject Zilbrysq correctly before you do it for the first time.

• Call your healthcare professional if you or your caregiver have any doubts about how to inject Zilbrysq correctly.

Do not use this medicinal product and return it to the pharmacy if:

• The pre-filled syringe has fallen.

Follow these steps every time you use Zilbrysq

1. Step 1: Preparation of the injection

Take 1 pre-filled syringe of Zilbrysq out of the refrigerator and place it on a clean and flat surface at room temperature for30 to 45 minutes before giving the injection.Do not heat it in any other way. Put the rest of the box back in the refrigerator and continue with Step b below.

1. Place the following items on a clean, flat, and well-lit surface, such as a table:

1. Examine the pre-filled syringe.

1. Choose the injection site.

1. Wash your handswith water and soap, and dry them with a clean towel.

1. Prepare the skin

1. Remove the needle cap

1. Pinch the skin

1. Insert the needle

1. Release the pinched skin

1. Inject the medicine

1. Release the plunger rod

1. Examine the injection site